BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19124491 · Received April 17, 2024

    Report

    Report Number
    2210968-2024-04422
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    November 7, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-04421. CITATION: UROLOGY 183: 106¿110, 2024; HTTPS://DOI.ORG/10.1016/J.UROLOGY.2023.11.002.

    Description of Event or Problem · 0

    TITLE: REPLICATING FLORENCE INTRACORPOREAL NEOBLADDER TECHNIQUE IN LAPAROSCOPIC RADICAL CYSTECTOMY: A RETROSPECTIVE STUDY. THE OBJECTIVE OF THE STUDY IS TO EVALUATE RETROSPECTIVELY THE FEASIBILITY OF FLORENCE ROBOTIC INTRACORPOREAL NEOBLADDER TECHNIQUE IN LAPAROSCOPIC RADICAL CYSTECTOMY. BETWEEN SEPTEMBER 2021 AND FEBRUARY 2023, 14 PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO UNDERWENT LAPAROSCOPIC RADICAL CYSTECTOMY AND FLORENCE ROBOTIC INTRACORPOREAL NEOBLADDER WERE INCLUDED IN THE STUDY. THERE WERE 11 MALES AND 3 FEMALES WITH A MEDIAN AGE OF 63 YEARS (RANGE, 55-74) AND A MEDIAN BMI OF 25 KG/M2 (RANGE, 24-27). DURING THE PROCEDURE, THE SEGMENT OF THE ILEUM, THAT WAS PLANNED TO FORM THE POUCH, WAS SECTIONED WITH A COMPETITOR ENDO GIA 60-MM STAPLER (MANUFACTURER: MEDTRONIC). THE URETHRAL-ILEAL ANASTOMOSIS WAS COMPLETED USING A RUNNING 3-0 STRATAFIX (ETHICON) SUTURE. THE RESTORATION OF BOWEL CONTINUITY WITH ILEAL-ILEAL LATERO-LATERAL ANASTOMOSIS WAS CARRIED OUT WITH A COMPETITOR ENDO GIA 60-MM STAPLER (MANUFACTURER: MEDTRONIC) AND A SUTURE WAS PLACED AT THE MESENTERIC PART OF THE ILEUM.THE POSTERIOR PLATE TOOK AN L CONFIGURATION AND WAS SUTURED WITH THE SAME SUTURE. THE RECONSTRUCTION OF THE NEOBLADDER NECK WAS COMPLETED WITH SUTURES FROM THE ANASTOMOSIS TO THE PROXIMAL END OF THE NEOBLADDER. BEFORE SUTURING THE NEOBLADDER ANTERIOR WALL, THE URETERS WERE INCISED AND APPROPRIATELY SPATULATED. MONO J URETERIC CATHETERS WERE INSERTED TO BOTH URETERS AND THE URETERS WERE REIMPLANTED TO THE LATERAL SIDES OF THE POUCH AND WERE SUTURED WITH FOUR INTERRUPTED 4-0 MONOCRYL (ETHICON) SUTURES. THE ANTERIOR PLATE WAS SUTURED WITH A COMPETITOR RUNNING 3-0 V- LOC SUTURE (MANUFACTURER: MEDTRONIC) SIMULATING A V SHAPE. AFTER THE COMPLETION OF THE PROCEDURE, THE WATERTIGHT INTEGRITY WAS TESTED BY INJECTING 50 ML OF NORMAL SALINE THROUGH THE URINARY CATHETER. THE URETERAL CATHETERS WERE BROUGHT OUTSIDE THE ABDOMINAL CAVITY THROUGH A SMALL SKIN INCISION AND A DRAIN WAS PLACED IN FRONT OF THE POUCH. REPORTED COMPLICATIONS INCLUDED URINARY INFECTION (N=2), ILEUS (N=1), UNSPECIFIED MINOR COMPLICATIONS AS CLAVIEN-DINDO (N=?). IN CONCLUSION, REPLICATING FLORENCE ROBOTIC INTRACORPOREAL NEOBLADDER IN LAPAROSCOPIC RADICAL CYSTECTOMY IS SAFE, FEASIBLE, AND REPEATABLE, BASED ON THE ENCOURAGING PERIOPERATIVE, ONCOLOGICAL, AND FUNCTIONAL OUTCOMES OF OUR STUDY. HOWEVER, FURTHER PROSPECTIVE STUDIES ON A LARGER SCALE ARE REQUIRED TO PROVE ITS LONG-TERM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868403 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention